FDA Label for Pain Relief Regular Strength, Aspirin Free
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF THE USER HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE USER IS
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Pain Relief Regular Strength, Aspirin Free Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Acetaminophen 325 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If The User Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If The User Is
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 10 days in adults
- redness or swelling is present
- pain gets worse or lasts more than 5 days in children under 12 years
- new symptoms occur
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed
- take 2 tablets every 4 to 6 hours while
symptoms last - do not take more than 10 tablets in
24 hours - do not take for more than 5 days
unless directed by a doctor - take 1 tablet every 4 to 6 hours while
symptoms last - do not take more than 5 tablets in
24 hours - do not take for more than 5 days
unless directed by a doctor
adults and children 12 years and over | |
children 6-11 years | |
children under 6 years | ask a doctor |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, povidone, sodium starch glycolate, stearic acid
Questions Or Comments?
1-800-426-9391
Principal Display Panel
COMPARE TO Regular Strength Tylenol®
active ingredient*
NDC 21130-904-12
Signature™
care
Quality Guaranteed
Regular Strength | Aspirin Free
Pain Relief
ACETAMINOPHEN 325 mg
Pain Reliever/
Fever Reducer
•Contains no aspirin
Actual Size
100 TABLETS
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
Johnson & Johnson Corporation, distributors of
Regular Strength Tylenol®.
50844 REV0417D10412
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
1-888-723-3929 www.betterlivingbrandsLLC.com
QUALITY & SATISFACTION 100% GUARANTEED OR YOUR MONEY BACK
* Please review the disclaimer below.